Nutritional Interventions for Type 2 Diabetes

(KP ENRICH Trial)

Recruiting at 1 trial location

Overseen By Richard Grant, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kaiser Permanente

Disqualifiers: Advanced kidney disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 6 months

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether financial assistance for purchasing healthy food, combined with free delivery, can improve blood sugar levels in individuals with type 2 diabetes who struggle to manage their condition. It compares two groups: one receives financial support and free delivery, while the other receives only free delivery. The trial aims to determine if this support reduces the need for medical services. Adults with type 2 diabetes who have consistently high blood sugar levels and are Kaiser Permanente members with Medi-Cal may be suitable candidates. Participants must have internet access to join. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on dietary changes rather than medication adjustments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that providing financial help for healthy foods and free home delivery is safe and well-received. Programs offering incentives for healthy eating show promise in managing conditions like type 2 diabetes. These efforts aim to improve diets by making nutritious foods more accessible.

Studies have found that free grocery delivery services support healthier eating habits, aiding in the management of type 2 diabetes by simplifying the choice of better foods. No major safety issues have been reported with these programs.

As this trial is in a late phase, substantial safety information is already available. Programs supporting healthy eating and food delivery are generally safe and can be a useful part of managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these nutritional interventions for type 2 diabetes because they address dietary challenges directly by providing financial support for healthy foods and ensuring access through free home delivery. Unlike traditional treatments that rely heavily on medications like metformin or insulin to manage blood sugar levels, this approach empowers patients to make healthier food choices with fewer barriers. By reducing financial and logistical obstacles, these interventions could lead to better diet adherence, potentially improving blood sugar control and overall health outcomes.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that making healthy foods more affordable can improve diets and help manage diabetes. In this trial, one group will receive financial support for healthy food items along with free home delivery. Studies find that this combination can enhance diabetes control and heart health. Providing these programs to individuals with diabetes who struggle to afford food can lead to significant health improvements.

Another group in this trial will receive only free home delivery. Evidence suggests that free home delivery can facilitate dietary changes by making diabetes-friendly foods more accessible. Some programs also offer education on managing diabetes alongside food delivery, which improves health outcomes. Overall, both approaches in this trial aim to increase access to healthy foods to enhance diabetes management. ^{1 3 6 7 8}

Who Is on the Research Team?

Claudia L Nau, PhD

Principal Investigator

Kaiser Permanente

Richard Grant, MD, MPH

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 2 diabetes, poor glycemic control (HbA1c ≥7.5%), and Medi-Cal insurance through Kaiser Permanente. Participants need internet access and can't have other private insurance, advanced kidney disease, be on dialysis or post-kidney transplant, or be pregnant.

Inclusion Criteria

Current access to the internet via computer or mobile device

No interpreter needed

I am a Kaiser Permanente member with only Medi-Cal insurance.

Exclusion Criteria

Known pregnancy at time of identification

My kidney function is very low, I'm on dialysis, or I've had a kidney transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 months of monetary support for healthy food or free delivery through the Instacart platform

6 months

Monthly assessments

Follow-up

Participants are monitored for changes in glycosylated hemoglobin levels and other health outcomes

6 months

Assessments at 6 and 12 months

Long-term follow-up

Participants' medical resource utilization and other outcomes are evaluated

12 months

Assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Financial support for healthy foods and free home delivery
• Free home delivery

Trial Overview The study tests if financial support for healthy food delivery affects blood sugar control in high-risk diabetic patients better than just free delivery. It's a randomized trial comparing two groups: one gets money towards healthy foods plus delivery; the other only gets the delivery service.

How Is the Trial Designed?

Group I: Free Delivery Experimental Treatment 1 Intervention

The control group will receive only free home delivery through the Instacart platform.

Group II: Financial Support and Free Delivery Experimental Treatment 1 Intervention

The intervention group will receive monthly financial support for healthy food items along with free home delivery through the Instacart platform.

Financial support for healthy foods and free home delivery is already approved in United States for the following indications:

Approved in United States as Financial Support for Healthy Foods and Free Home Delivery for:

• Type 2 Diabetes Mellitus with Suboptimal Glycemic Control

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Published Research Related to This Trial

The 'Prevention Produce' program, which combined fruit and vegetable prescriptions with a month-long educational curriculum, successfully increased fruit and vegetable consumption among nine families at risk of chronic disease and food insecurity.

Participants reported a greater understanding of the health benefits of produce, and the mentorship aspect of the program was positively received by both families and medical students, highlighting its potential as a model for integrating preventive health strategies in healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. Forbes, JM., Forbes, CR., Lehman, E., et al.[2020]

A pilot food prescription program called Fresh Start Food Rx provided biweekly fresh fruits and vegetables and dietary education to four uninsured patients in South Miami, showing potential to improve dietary behaviors and attitudes toward healthy eating.

Participants reported an increase in the number of days they consumed fruits per week and a rise in vegetable servings, indicating that access to healthy foods and education can positively influence eating habits and perceptions about nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. Oliveira, JB., To, L., De La Cruz, Y., et al.[2021]

The Food Rx program, a collaborative initiative involving a university, Walgreens, and local health centers, aims to improve healthy eating among diabetes patients in underserved communities by providing food prescriptions that promote behavior change and connect patients to local resources.

Preliminary implementation results suggest that Food Rx effectively integrates community resources into healthcare settings, showing potential as a model for supporting the health of underserved patients, although it is still in the early stages of development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Rx: a community-university partnership to prescribe healthy eating on the South Side of Chicago. Goddu, AP., Roberson, TS., Raffel, KE., et al.[2018]

Participants in a medically-tailored meal program for individuals with type 2 diabetes reported high satisfaction and noted improvements in their quality of life and diabetes management, highlighting the program's effectiveness.

The study emphasized the importance of culturally appropriate meals and suggested that combining these meal programs with diabetes education could enhance their impact on managing diabetes and reducing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. Berkowitz, SA., Shahid, NN., Terranova, J., et al.[2020]

The study identified key facilitators for the success of Fruit and Vegetable Prescription (FVRx) Programs in Georgia, including the importance of accessible programming and dedicated providers, which can enhance participation among vulnerable patients.

Barriers such as participants' challenging life circumstances and concerns about program sustainability were also highlighted, indicating that future program designs should address these issues to improve effectiveness and longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies and Challenges: Qualitative Lessons Learned From Georgia Produce Prescription Programs. Newman, T., Lee, JS.[2022]

A prescription (PRx) program in rural Eastern North Carolina provided patients with type 2 diabetes weekly home deliveries of fruits and vegetables, leading to high patient satisfaction and increased consumption of produce.

The program not only improved dietary habits but also significantly enhanced glycemic control, demonstrating the effectiveness of combining food access with nutrition education and culinary resources for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of the Delivery-Based HEALED Produce Rx Program for Uninsured Patients With Diabetes in Rural Eastern North Carolina. Sastre, LR., Stroud, B., Smith, E., et al.[2023]

A pilot study involving adults with type 2 diabetes and food insecurity showed that a collaboration between a food bank and a health system to deliver tailored food was feasible and led to high participant satisfaction over 24 weeks.

While the intervention improved food security and overall health status, it did not significantly change HbA1c levels or healthcare utilization, suggesting that while food support is beneficial, additional strategies may be needed to improve glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Collaborative Pilot to Support Patients With Diabetes Through Tailored Food Box Home Delivery. Kempainen, S., Cutts, DB., Robinson-O'Brien, R., et al.[2023]

The Complete Eats Rx program significantly improved food security and diet quality among SNAP participants by incentivizing the purchase of fruits and vegetables, as reported by 26 participants in qualitative sessions.

Barriers to the program's effectiveness included limited supermarket options for redeeming incentives and challenges related to the cost and accessibility of healthy foods, suggesting that expanding partnerships with more local grocers and improving the shopping experience could enhance program usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Study on Participant Perceptions of a Supermarket Fruit and Vegetable Incentive Program. Riemer, S., Walkinshaw, LP., Auvinen, A., et al.[2023]

A clinic-based intervention that included food insecurity screening and nutrition education led to a significant decrease in HbA1c levels among patients with diabetes, indicating improved glycemic control.

Food secure participants showed greater improvements in HbA1c compared to food insecure participants, suggesting that additional support may be needed for those facing food insecurity to achieve similar health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foods for Health: An Integrated Social Medical Approach to Food Insecurity Among Patients With Diabetes. Blitstein, JL., Lazar, D., Gregory, K., et al.[2022]

A systematic review of 10 studies on food provision programs for patients with type 2 diabetes or prediabetes showed that those including nutrition education consistently reduced HbA1c levels, indicating improved diabetes management.

Programs varied widely in their design and implementation, but those that incorporated nutrition education—covering topics like general nutrition and fruit/vegetable consumption—tended to yield better dietary quality and health outcomes compared to those without such education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. Schier, HE., Chetty, KS., Garrity, K., et al.[2023]

Citations

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Healthy food prescription incentive programme for adults ... Healthy food prescription programmes may reduce food insecurity and support patients to improve their diet quality, prevent diabetes complications and avoid ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/10/1783/163117/Health-and-Economic-Impact-and-Cost-effectiveness

Health and Economic Impact and Cost-effectiveness of ... Produce prescription (PRx) programs have been shown to result in improved dietary quality, diabetes control, and cardiometabolic outcomes.

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Voucher for Healthy Foods and Diabetes Control In this randomized clinical trial of 390 adults, a monthly voucher that allowed access to healthy foods did not improve diabetes control but did ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.029215

Health and Economic Impacts of Implementing Produce ... Our model suggests that implementing produce prescriptions among US adults with diabetes and food insecurity would generate substantial health gains and be ...

5. tuftsfoodismedicine.org tuftsfoodismedicine.org/wp-content/uploads/2023/09/Tufts_True_Cost_of_FIM_Case-Study_Report_Sep_2023.pdf

True Cost of Food: Food is Medicine Case Study Poor nutrition and food insecurity are major drivers of poor health outcomes and excess healthcare spending in the United States.

6. odphp.health.gov odphp.health.gov/sites/default/files/2024-09/Food%20Is%20Medicine%20Landscape%20Summary%20FINAL%20508.pdf

Food Is Medicine Landscape Summary Medically tailored groceries programs provide food boxes selected by an RDN to assist individuals with managing diet related illnesses. • Food ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10753472/

Healthcare-based food assistance programmes in the ... This scoping review aimed to identify the breadth of healthcare-based food assistance programmes in the United States and organize them into ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06242808

Medically Tailored Groceries and Food Resource Coaching Eating healthy foods can help people manage health problems, like Type 2 diabetes and heart disease. Many people want to eat healthier, but changing eating ...